EP3424464B1 - Intraocular lens system for implantation into a lens capsule of an eye of human or animal being - Google Patents

Intraocular lens system for implantation into a lens capsule of an eye of human or animal being Download PDF

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Publication number
EP3424464B1
EP3424464B1 EP18182179.4A EP18182179A EP3424464B1 EP 3424464 B1 EP3424464 B1 EP 3424464B1 EP 18182179 A EP18182179 A EP 18182179A EP 3424464 B1 EP3424464 B1 EP 3424464B1
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EP
European Patent Office
Prior art keywords
component
primary
body part
optical
primary component
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EP18182179.4A
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German (de)
French (fr)
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EP3424464A1 (en
Inventor
Arnaldo GONÇALVES
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SHARPSIGHT BV
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Sharpsight BV
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Priority claimed from NL2019196A external-priority patent/NL2019196B1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • A61F2/1632Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside for changing radial position, i.e. perpendicularly to the visual axis when implanted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1648Multipart lenses

Definitions

  • This disclosure relates to an intraocular lens system for implantation into a lens capsule of an eye of human or animal being.
  • the eye of any living being, but in particular of a human or animal being is the sense organ capable of vision.
  • the lens in the eye can be altered in shape resulting in a change of the focal distance of the eye. Through this phenomenon called accommodation the eye is allowed to focus on objects at various distances.
  • the eye - under normal physical functionality - is able to form a sharp image of the object of interest on the retina.
  • cataract Due to age or disease the lens can become less transparent or cloudy, and as such the amount of light impinging on the lens will diminish, less light will therefor reach the retina and vision (its sharpness) of the human or animal being will deteriorate. In medial terms, such deficiency in the lens of the eye is categorized as cataract. Treating cataract involves the surgical removal of the lens from the capsular bag and replacing the affected lens with an artificial intraocular lens (IOL) in the capsular bag.
  • IOL intraocular lens
  • the surgical technique for replacing an affected, cataractous lens with an artificial IOL is called phacoemulsification.
  • This surgical technique can also be used to achieve a refractive goal by patients, that have no cataract at all.
  • the surgical procedure starts with creating a small opening in the anterior side of the capsular bag.
  • a thin phacoemulsification-cutting tip is inserted through said opening and into the affected lens.
  • the affected lens is liquefies, allowing the lens to be removed from the capsule bag through aspiration.
  • an artificial IOL is placed inside the now empty capsular bag.
  • the replacement of the affected lens with the IOL has provided the desired optical (refractive) correction.
  • the treatment may result in an erroneous or less positive correction and that the patient may need correction, such as a stronger refractive correction, an astigmatism correction, or a multifocal correction.
  • the implanted lens (IOL) can get displacemed inside the lens capsule (subluxation) or it can be lightly positioned outside the desirable optical axis. In certain instances is might be necessary to remove the IOL and replace it with a new IOL. This might tend to additional health issues and discomfort to the patient and in particular to irrevocable damage to the capsular bag, such as posterior rupture.
  • WO2013/112589 discloses a modular IOL consisting of a base component and a lens component allowing for the removal and replacement of the lens component part in the event of an incorrect optical correction.
  • this invention is limited by just being able to remove the incorrect lens.
  • This prior art document requires the insertion of the surgical tool into the capsular bag to remove the incorrect lens component and replace it with a new one and is not able to correct the position of the optical lens component into the optical as, when its base seems to be displaced from this desirable position relative to the optical axis.
  • WO 2016/122805 discloses a modular IOL systems including a base and a lens, wherein the lens includes fixed and actuatable tabs for connection to the base.
  • This invention also provides the option of providing a modular IOL allowing to correct or to modify the final, optical result without the need to remove (any part of) the IOL inside the capsular bag which makes it easier to manipulate and with less risk of damage of the capsular bag.
  • an intraocular lens system for implantation into a lens capsule of an eye of human or animal body comprising:
  • the modular IOL it is possible after implanting the modular IOL to adapt the orientation of the secondary component within the capsular bag and as such to adapt the optical performance of the modular IOL without the need of removal and replacement nor of manipulation of the capsular bag. Also the location of a part of the first primary component within the lens capsule provides additional support to the lens capsule.
  • the second primary component body part is configured to be positioned at the same level as the anterior surface line of the lens capsule and in the posterior chamber of the eye.
  • the primary component includes a center hole extending in an anterior-posterior direction, wherein the hole is sized and configured to receive the secondary component. This allows for an easy access and correction of the secondary, lens component relative to the primary, base component.
  • the optical body of the secondary component is accommodated within the plane formed by the flat configuration of the second body part of the primary component.
  • optical body of the secondary component is positioned outside the plane formed by the flat configuration of the second body part of the primary component. Albeit its enlarged dimension seen in the direction of the optical axis of the eye still embodiment allows for easier access and manipulation of the secondary component for optical correction.
  • the primary component is provided with two or more primary support flanges extending from the first body part.
  • the support flanges extends and abut against inner circumference of the capsular bag and thus provides stability to the base component and allow a more efficient correction of the secondary, optical component relative to the stabilized primary, base component.
  • said primary support flanges extend in the plane formed by the flat configuration of the first body part of the primary component, thus maintaining a limited dimension seen in the direction of the optical axis of the eye.
  • said primary support flanges extend outside the plane formed by the flat configuration of the first body part of the primary component, thus positioning the primary base component and as such also the secondary, optical component in the anterior direction improving access and manipulation of the latter.
  • the secondary component comprises multiple secondary flanges extending away from the optical axis and in the plane formed by the optical body of the secondary component, wherein each secondary flange is movable accommodated in an flange opening provided in the circumference of the second body part of the primary component.
  • each secondary flange is provided with an opening, which serves as the contact point for a tip or pin shaped surgical tool for repositioning the secondary component relative to the primary component.
  • each secondary flange is provided with a rounded edge, said rounded edge arranged for hooking around the outer circumference of first primary component body part. This allows for a secure mounting of the secondary component to the primary component.
  • the primary component constitutes a support and the secondary component constitutes a lens.
  • the primary component is manufactured from a material having a contrast enhancing color relative to the secondary, optical component.
  • contrast enhancements e.g. by using color differences it is possible to the optical system to enhance a better contrast resolution and a better visual acuity as well as reducing possible complains of disfothopsy due to restricting light dispersion through the periphery of the optic system.
  • Figure 1 depicts a cross section of an eye, in particular a cross section of the eye 100 of a human being.
  • the eye 100 is a sense organ capable of vision having an almost spherical configuration. Seen in the direction of light impinging on the eye, the anterior, frontal side of the eye 100 is formed by the cornea 107 having a stronger curvature comparted to the posterior side, being the sclera 101.
  • the limbus connects the cornea 107 and the sclera 101.
  • the cornea 107, the iris 110 and the lens capsule 106 form the anterior chamber 108 filled with aqueous humor liquid. Behind the lens 106 the vitreous body 105 is filled with vitreous gel.
  • the lens 106 is suspended in the eye by means of the ciliary body 111 composed of ciliary muscle and fibers.
  • Reference numeral 109 denoted the posterior chamber present between the lens 106, the ciliary body 111 and the iris 110.
  • the fundus or area opposite to the lens 106 at the posterior side of the eye 100 includes the macula 103, as well as the retina, being the innermost tissue layer containing the rod and cone cells. Also shown is the optic nerve 104 leaving the eye 100 at its posterior side towards the brains.
  • Reference numeral 102 denotes the choroid.
  • the clear lens 106 is a transparent, biconvex structure in the eye that, along with the cornea 107 refract impinging light to be focused on the retina.
  • the shape of the lens 106 can be changed resulting in a change of the focal distance of the eye 100 allowing the eye to focus (accommodation) on objects at various distances.
  • the eye - under normal physical functionality - is able to form a sharp image of the object of interest on the retina.
  • the lens 106 is composed of three parts being the lens capsule, the lens epithelium, and the lens fibers.
  • the lens capsule forms the outermost layer of the lens and the lens fibers form the bulk of the interior of the lens.
  • the cells of the lens epithelium, located between the lens capsule and the outermost layer of lens fibers, are found predominantly on the anterior side of the lens but extend posteriorly just beyond the equator.
  • the lens capsule is a smooth, transparent basement membrane that completely surrounds the lens.
  • the lens capsule is elastic and is composed of collagen and its shape can be changed for focusing purposes, also called accommodation of the lens 106.
  • a modular intraocular lens assembly can be implemented to treat cataracts, large optical errors in myopic (near-sighted), hyperopic (far-sighted), and astigmatic eyes, ectopia lentis, aphakia, pseudophakia, and nuclear sclerosis.
  • FIG. 2 discloses a first embodiment of a modular intraocular lens system (IOL) according to an example of the invention.
  • the IOL is indicated with reference numeral 1 and is composed of a primary component 10 which serves as a base component for implant in the capsular bag of an eye as described in combination with Figure 1 above.
  • the intraocular primary, base component 10 interacts with an intraocular secondary, optical component indicated with reference numeral 20.
  • the intraocular primary, base component comprises a body 10 exhibiting a flat configuration and comprises a first primary component body part indicated with reference numeral 10a and a second primary component body part indicated with reference numeral 10b.
  • the first primary component body part 10a of the intraocular primary component body 10 is configured to fit within the lens capsule or capsular bag 106 of the eye 100.
  • the first primary component body part 10a of the body 10 has an outer dimension or equatorial perimeter which is equal to the inner perimeter of the capsular bag or lens capsule 106.
  • the second primary component body part 10b of the intraocular primary component body 10 is configured to be positioned outside the lens capsule or capsular bag 106 and in the posterior chamber 109 of the eye. In a preferred, yet alternative embodiment the second primary component body part is configured to be positioned at the same level as the anterior surface line of the lens capsule and in the posterior chamber of the eye.
  • the outer perimeter or outer circumference of the second primary component body part 10b of the intraocular primary, base component 10 is indicated with reference numeral 11a.
  • the first primary component body part 10a of the primary, base component 10 may have an equatorial perimeter greater than or equal or even smaller to the inner, capsulorhexis perimeter of the capsular bag 106.
  • the intraocular secondary, optical component 20 consists of an optical body 21 with an optical axis 23 which also is the cylindrical symmetric axis of the complete assembly of the intraocular lens system (primary and secondary components assembled together).
  • the outer dimensions of the intraocular secondary, optical component 20 are less than the outer dimensions of the second primary component body part 10b of the intraocular primary, base component 10. This allows for and guarantees a proper support and mounting of the secondary component 20 on (and/or in) the second primary component body part 10b.
  • the secondary component may have an outer dimension , which is equal or smaller than than the capsulorhexis perimeter.
  • the primary, base component 10 and the secondary, optical component 20 of the modular IOL system 1 may be formed of the same, similar or different materials.
  • Suitable materials may include, for example, acrylate, base materials, silicon materials, hydrophobic polymers or hydrophilic polymers. Such materials may have shape-memory characteristics.
  • materials comprising the optical parts of the IOL system can be silicon, PMMA, hydrogels, hydrophobic acrylic, hydrophilic acrylic and/or other transparent materials commonly used for intraocular lenses.
  • the non-optical parts of the modular IOL assembly might include nitinol, polyethylene sulfone and/or polyimide.
  • the modular IOL system according to the invention is composed of two components, indicated already as the intraocular primary (base) component 10 (comprising the interconnected first and second primary body parts 10a and 10b) and intraocular secondary (optical) component 20.
  • the intraocular primary, base component functions as a support base for accommodating the intraocular secondary, optical component.
  • the primary, base component 10 only performs a support function and does not provide any optical correction, the latter function is solely or predominantly performed by the intraocular secondary, optical component 20.
  • the primary, base component 10 does provide some optical correction together with the secondary, optical component 20 and as such the modular IOL system is composed of a primary lens and a secondary lens part.
  • the positioning or implanting of the modular IOL system 1 in the capsular bag of the eye 100 is performed by a suitable, known ophthalmology surgical tools, in which the modular IOL is accommodated in a folded or rolled-up manner.
  • the rolled-up modular IOL system is to be ejected from or driven out the surgical tool into the capsular bag and during the ejection or insertion in the capsular bag the rolled-up modular IOL system automatically unrolls into its flat configuration as depicted in Figure 2 . In the unrolled configuration the modular IOL system occupies the space in the capsular bag.
  • the second primary component body part 10b of the primary, base component 10 is provided with a center hole 11c defining an inner circumference 11b.
  • the secondary, optical component 20, and in particular the optical body 21 of the secondary, optical component 20, can be accommodated.
  • the outer circumference 21a of the optical body 21 of the secondary, optical component 20 is more or less conformal to the inner circumference 11b of the center hole 11c provided in the second primary component body part 10b of the primary, base component 10.
  • the outer circumference 21a of the optical body 21 of the secondary, optical component 20 is slightly smaller than the inner circumference 11b of the center hole 11c. This embodiment is depicted in Figure 4 and Figure 5 .
  • the accommodation of the optical body 21 of the secondary, base component 20 in the center hole 11c of the second primary component body part 10b of the primary, base component 10 allows for an adjustment of the optical body 21 (hence the optical axis 23 thereof) relative to the primary, base component 10.
  • the modular IOL according to the examples as shown in Figure 2 (and Figure 3 ) as well as in Figure 4 (and Figure 5 ) it is possible to correct the optical dioptric characteristic of the modular IOL. This is performed by replacement of the secondary, optical component 20 (the optical lens) with another example of a secondary, optical component without the removal of the complete IOL from the capsular bag.
  • the modular IOL according to the examples of the present invention also allows for an easy manipulation, displacement or even removal of the secondary, optical component accommodated in the second primary component body part 10b positioned in the posterior chamber 109 relative to the first primary component body part 10a the primary, base component 10 being deployed in the capsular bag 106.
  • the optical body 21 can be displaced relative to the primary, base component 10 by rotating around the optical axis 23 or, as shown in the example of Figure 4 and Figure 5 , by displacing the optical body 21 in a transverse direction over a certain distance relative to the optical axis 23 within the oversized center hole 11c provided in the second primary component body part 10b of the primary, base component 10.
  • the secondary, optical component 20 is provided with several secondary flanges, two flanges in Figure 2 indicated with reference numeral 22a-22b (in Figure 2 and Figure 3 ) and four flanges indicated with reference numerals 22a-22d in Figures 4 and 5 .
  • the secondary flanges 22a-22d are accommodated in suitable flange openings 12a-12d provided in the second primary component body part 10b of the primary, base component 10.
  • the first primary component body part 10b of the primary, base component 10 is provided with several support flanges 14a-14d.
  • the support flanges 14a-14d extend from the first primary component body part 10a of the primary, base component 10.
  • the support flanges 14a-14d extend outside and away from the plane formed by the flat configuration of the first primary component body part 10a of the primary, base component 10.
  • the second primary component body part 10b of the primary, base component 10 together with the secondary, optical component 20 contained therein are positioned further in the anterior direction which improves access and manipulation of the secondary, optical component 20 in order to adjust or improve its orientation relative to the optical axis 23 and/or the primary, base component 10.
  • the support flanges 14a-14d extend away from the outer circumference of the first primary component body part 10a of the primary, base component 10, whereas the support flanges 14a-14d are also positioned and extending within the plane formed by the first primary component body part 10a of the primary, base component 10.
  • This latter configuration is shown in Figures 4 and 5 resulting in a modular IOL having a limited dimension seen in the direction of the optical axis of the eye (anterior-posterior direction).
  • the support flanges 14a-14d extending from the first primary component body part 10a of the primary, base component 10 abut against the inner circumference of the capsular bag 106 and as such provide a stability to the primary, base component and also allow a more efficient correction of the secondary, optical component 20 relative to the stabilized primary, base component 10.
  • Adjusting the position of the secondary, optical component 20 relative to the second primary component body part 10b of the primary, base component 10 is further effectuated due to the presence of adjustment openings 24a-24d in every secondary flange 22a-22d.
  • the adjustment openings 24a-24d serve as contact or gripping point for the tip of a surgical tool such as sinskey hooks for displacing the secondary, optical component 20 accommodated inside the center hole 11c of the second primary component body part 10b of the primary, base component 10 relative to the optical axis 23.
  • each secondary flange 22a-22d is accommodated in a flange opening 12a-12d of the second primary component body part 10b of the primary, base component 10
  • manipulation of the secondary, base component 20 using the tip of a surgical tool positioned in one of the adjustment or gripping openings 24a-24d may result in a limited rotation of the optical body 20 around the optical axis 23.
  • a (slight) transverse displacement of the optical body 20 relative to the optical axis 23 can herewith be effected, for example in either X- or Y-direction wherein the X- and Y-directions denote orthogonal axes both intersecting the optical axis 23 and running across the opposite secondary flanges 22a-22b and 22c-22d respectively.
  • the adjustment or gripping openings 24a-24b are positioned exactly opposite to each other on an equatorial or diametrical line crossing the optical axis 23.
  • inventions as shown in Figures 2 and 3 as well as in Figures 4 and 5 allow for a less drastic replacement of the secondary, optical component 20 contained in the second primary component body part 10b from the static first primary component body part 10a of the primary, base component 10 which first body part 10a remains in the capsular bag 106, as outlined before.
  • the examples also allow for correction of the orientation of the secondary, optical component 20 relative to the macula and retina of the eye.
  • FIG. 6 yet another example of an embodiment of an intraocular lens system according to the invention is shown, combined with Figure 7 showing the embodiment of Figure 6 in an assembled state and Figure 8 showing a detailed view of the embodiment of Figure 6 in the assembled state of Figure 7 . Also in the Figures 6-8 like parts are denoted with like reference numerals as used in the Figures 1-5 .
  • the intraocular primary, base component comprises a body 10 exhibiting a flat configuration and comprises a first primary component body part indicated with reference numeral 10a and a second primary component body part indicated with reference numeral 10b.
  • the first primary component body part 10a of the intraocular primary component body 10 is configured to fit within the lens capsule or capsular bag 106 of the eye 100.
  • the first primary component body part 10a of the body 10 has an outer dimension or equatorial perimeter which is equal to the inner perimeter of the capsular bag or lens capsule 106.
  • the second primary component body part 10b of the intraocular primary component body 10 is configured to be positioned outside the lens capsule or capsular bag 106 and in the posterior chamber 109 of the eye.
  • the outer perimeter or outer circumference of the second primary component body part 10b of the intraocular primary, base component 10 is indicated with reference numeral 11a.
  • the intraocular secondary, optical component 20 consists of an optical body 21 having an optical axis 23, which also is the cylindrical symmetric axis of the complete assembly of the intraocular lens system (primary and secondary components assembled together).
  • the secondary, optical component 20 is provided with several secondary flanges at its the outer circumference 21a, in particular four flanges indicated with reference numerals 22a-22d (similar as in Figures 4 and 5 ).
  • two flanges 22a-22b can be implemented similar as the embodiment in Figure 2 and 3 , or even three flanges. In all flange configurations having 2, 3 or 4 flanges, it is preferred to have the flanges positioned equidistant at the outer circumference 21a of optical body of secondary, optical component 20.
  • each flange 22a-22d is provided with a rounded edge 25, a detail of the rounded edge 25 being shown in Figure 8 .
  • Said rounded edge 25 is arranged for hooking around the outer circumference edge 11a of first primary component body part 10.
  • the hooking functionality is effectuated by a slight deformation of each flange 22a-22d due to its flexible material by a bending force and hooking the rounded edge 25 around the outer circumference edge 11a as shown in Figure 8 , allowing the rounded edge 25 to snap or click behind the edge 11a and creating an interlocking connection between the secondary, optical component 20 on the second primary component body part 10b of the intraocular primary component body 10.
  • This interlocking connection can easily be released or removed by applying a proper deformation force on each flange 22a-22d, thereby unhooking the rounded edge 25 from the circumference edge 11a for example for replacement of the secondary, optical component 20.
  • This interlocking connection also allows for an easy adjustment of the secondary, optical component 20 by rotating of the optical body 21 relative to the primary, base component 10 around the optical axis 23.
  • the adjustment of the secondary, optical component 20 by rotating relative to the second primary component body part 10b of the primary, base component 10 can be facilitated as additionally the outer circumference edge 11a is provided with one or more support knobs 26. These knobs 26 support the secondary, optical component 20 on several distinct supporting points thereby reducing the overall contact surface between the secondary, optical component 20 and the second primary component body part 10b, thus reducing friction during adjustments.
  • the intraocular primary, base component comprises a body 10 exhibiting a flat configuration and comprises a first primary component body part indicated with reference numeral 10a and a second primary component body part indicated with reference numeral 10b.
  • the first primary component body part 10a of the intraocular primary component body 10 is configured to fit within the lens capsule or capsular bag 106 of the eye 100.
  • the first primary component body part 10a of the body 10 has an outer dimension or equatorial perimeter which is equal to the inner perimeter of the capsular bag or lens capsule 106.
  • the second primary component body part 10b of the intraocular primary component body 10 is configured to be positioned outside the lens capsule or capsular bag 106 and in the posterior chamber 109 of the eye.
  • the secondary, optical component 20 is provided with several (four) flanges indicated with reference numerals 22a-22d.
  • the secondary flanges 22a-22d are accommodated in suitable flange openings 12a-12d provided in the second primary component body part 10b of the primary, base component 10.
  • a proper confinement of the secondary, optical component 20 in the second primary component body part 10b of the primary, base component 10 is guaranteed, as the first primary component body part 10a of the primary, base component 10 is properly and securely placed inside the capsular bag 106 and thus forms a stable support face for the secondary component 20.
  • the first primary component body part 10b of the primary, base component 10 is provided with several support flanges 14a-14b.
  • the support flanges 14a-14b extend from the first primary component body part 10a of the primary, base component 10.
  • the support flanges 14a-14b extend outside and away from the plane formed by the flat configuration of the first primary component body part 10a of the primary, base component 10.
  • the second primary component body part 10b of the primary, base component 10 together with the secondary, optical component 20 contained therein are positioned further in the anterior direction which improves access and manipulation of the secondary, optical component 20 in order to adjust or improve its orientation relative to the optical axis 23 and/or the primary, base component 10.
  • the support flanges 14a-14b extending from the first primary component body part 10a of the primary, base component 10 abut against the inner circumference of the capsular bag 106 and as such provide a stability to the primary, base component and also allow a more efficient correction of the secondary, optical component 20 relative to the stabilized primary, base component 10.
  • the first primary component body part of the primary component may provide additional support to the lens capsule, whereas alternatively the second primary component body part is configured to be positioned at the same level as the anterior surface line of the lens capsule and in the posterior chamber of the eye. Additionally the contact between the optic system and the posterior surface of the lenticular capsule is prevented and thus the formation of posterior capsular opacity is avoided.
  • the static primary, base component 10, which is to receive the secondary, optical component 20 in the second primary component body part 10b can be chosen to be manufactured from a material having contrast enhancing color. Such a color contrasts with the color of the material of the secondary, optical component 20.
  • the color of the material of the static primary, base component 10 can be darker that the color of the material of the secondary, optical component 20.
  • the static primary, base component 10 can also be provided locally with a contrast enhancing color.
  • certain parts of the static primary, base component 10 can have a color difference with respect to the color of the material of the secondary, optical component 20 as well as with respect to other parts of the static primary, base component 10 at locations on the static primary, base component 10 closely or near the secondary, optical component 20 being accommodated in the second primary component body part 10b of the primary, base component 10.
  • said color difference can be applied to the circumference 11b of the center hole 13, thereby enhancing the contrast between the secondary, optical component 20 being accommodated in the center hole 13.
  • contrast enhancements color differences
  • this also avoids the creation of glare at night.

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Description

    BACKGROUND OF THE INVENTION
  • This disclosure relates to an intraocular lens system for implantation into a lens capsule of an eye of human or animal being.
  • The eye of any living being, but in particular of a human or animal being is the sense organ capable of vision. The lens in the eye can be altered in shape resulting in a change of the focal distance of the eye. Through this phenomenon called accommodation the eye is allowed to focus on objects at various distances. Herewith the eye - under normal physical functionality - is able to form a sharp image of the object of interest on the retina.
  • Due to age or disease the lens can become less transparent or cloudy, and as such the amount of light impinging on the lens will diminish, less light will therefor reach the retina and vision (its sharpness) of the human or animal being will deteriorate. In medial terms, such deficiency in the lens of the eye is categorized as cataract. Treating cataract involves the surgical removal of the lens from the capsular bag and replacing the affected lens with an artificial intraocular lens (IOL) in the capsular bag.
  • The surgical technique for replacing an affected, cataractous lens with an artificial IOL is called phacoemulsification. This surgical technique can also be used to achieve a refractive goal by patients, that have no cataract at all. The surgical procedure starts with creating a small opening in the anterior side of the capsular bag. Next a thin phacoemulsification-cutting tip is inserted through said opening and into the affected lens. Through ultrasonic vibrations the affected lens is liquefies, allowing the lens to be removed from the capsule bag through aspiration. After removal of the affected, cataractous lens an artificial IOL is placed inside the now empty capsular bag.
  • After the phacoemulsification treatment it is to be determined whether the replacement of the affected lens with the IOL has provided the desired optical (refractive) correction. Unfortunate in several instances, the treatment may result in an erroneous or less positive correction and that the patient may need correction, such as a stronger refractive correction, an astigmatism correction, or a multifocal correction. Other possibility is that the implanted lens (IOL) can get displacemed inside the lens capsule (subluxation) or it can be lightly positioned outside the desirable optical axis. In certain instances is might be necessary to remove the IOL and replace it with a new IOL. This might tend to additional health issues and discomfort to the patient and in particular to irrevocable damage to the capsular bag, such as posterior rupture.
  • WO2013/112589 discloses a modular IOL consisting of a base component and a lens component allowing for the removal and replacement of the lens component part in the event of an incorrect optical correction. However this invention is limited by just being able to remove the incorrect lens. This prior art document requires the insertion of the surgical tool into the capsular bag to remove the incorrect lens component and replace it with a new one and is not able to correct the position of the optical lens component into the optical as, when its base seems to be displaced from this desirable position relative to the optical axis. WO 2016/122805 discloses a modular IOL systems including a base and a lens, wherein the lens includes fixed and actuatable tabs for connection to the base.
  • It is a goal of the present invention to provide a modular IOL allowing correct or modify the final, optical result without the need to remove (any part of) the IOL or manipulate the capsular bag. In particular, it is the goal of the present invention to provide a modular IOL allowing not only the correction of the optical dioptric results by removal of the optical lens, but also to allow the displacement of the optical lens inside the desirable optical axis, despite of the position of the base component. This invention also provides the option of providing a modular IOL allowing to correct or to modify the final, optical result without the need to remove (any part of) the IOL inside the capsular bag which makes it easier to manipulate and with less risk of damage of the capsular bag.
  • SUMMARY OF THE DISCLOSURE
  • In a first aspect, an intraocular lens system for implantation into a lens capsule of an eye of human or animal body is presented, said lens capsule having a capsulorhexis perimeter, said intraocular lens system comprising:
    1. i) an intraocular primary component having a body exhibiting a flat configuration; and
    2. ii) an intraocular secondary component having an optical body with an optical axis,
    wherein the primary component includes a first primary component body part configured to fit within the lens capsule and a second primary component body part configured to be positioned outside the lens capsule and in the posterior chamber of the eye and wherein the second primary component body part is configured to releasably receive the secondary component in the posterior chamber of the eye to provide optical correction, such that the secondary component is movable relative to the primary component.
  • Herewith it is possible after implanting the modular IOL to adapt the orientation of the secondary component within the capsular bag and as such to adapt the optical performance of the modular IOL without the need of removal and replacement nor of manipulation of the capsular bag. Also the location of a part of the first primary component within the lens capsule provides additional support to the lens capsule.
  • In another example the second primary component body part is configured to be positioned at the same level as the anterior surface line of the lens capsule and in the posterior chamber of the eye.
  • In a further example the primary component includes a center hole extending in an anterior-posterior direction, wherein the hole is sized and configured to receive the secondary component. This allows for an easy access and correction of the secondary, lens component relative to the primary, base component.
  • In an example having limited dimensions seen in the direction of the optical axis of the eye the optical body of the secondary component is accommodated within the plane formed by the flat configuration of the second body part of the primary component.
  • In another example the optical body of the secondary component is positioned outside the plane formed by the flat configuration of the second body part of the primary component. Albeit its enlarged dimension seen in the direction of the optical axis of the eye still embodiment allows for easier access and manipulation of the secondary component for optical correction.
  • In an example which guarantees a stable and fixed positioning of the primary component in the capsular bag, the primary component is provided with two or more primary support flanges extending from the first body part. The support flanges extends and abut against inner circumference of the capsular bag and thus provides stability to the base component and allow a more efficient correction of the secondary, optical component relative to the stabilized primary, base component.
  • In particular said primary support flanges extend in the plane formed by the flat configuration of the first body part of the primary component, thus maintaining a limited dimension seen in the direction of the optical axis of the eye.
  • In yet another example said primary support flanges extend outside the plane formed by the flat configuration of the first body part of the primary component, thus positioning the primary base component and as such also the secondary, optical component in the anterior direction improving access and manipulation of the latter.
  • Furthermore in an example the secondary component comprises multiple secondary flanges extending away from the optical axis and in the plane formed by the optical body of the secondary component, wherein each secondary flange is movable accommodated in an flange opening provided in the circumference of the second body part of the primary component. This guarantees a movable yet enclosed secondary, optical component relative to the fixed primary, base component.
  • In an example each secondary flange is provided with an opening, which serves as the contact point for a tip or pin shaped surgical tool for repositioning the secondary component relative to the primary component.
  • More in particular each secondary flange is provided with a rounded edge, said rounded edge arranged for hooking around the outer circumference of first primary component body part. This allows for a secure mounting of the secondary component to the primary component.
  • In yet another example the primary component constitutes a support and the secondary component constitutes a lens.
  • In yet another embodiment the primary component is manufactured from a material having a contrast enhancing color relative to the secondary, optical component. Such contrast enhancements e.g. by using color differences it is possible to the optical system to enhance a better contrast resolution and a better visual acuity as well as reducing possible complains of disfothopsy due to restricting light dispersion through the periphery of the optic system.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • The accompanying drawings facilitate an understanding of the various embodiments:
    • Figure 1 a cross section of an eye of a human being;
    • Figure 2 is an example of an intraocular lens system for implantation into a lens capsule of an eye;
    • Figure 3 is a cross section of the example of Figure 2;
    • Figure 4 is another example intraocular lens system for implantation into a lens capsule of an eye;
    • Figure 5 is a cross section of the example of Figure 4;
    • Figure 6 yet another example of an embodiment of an intraocular lens system;
    • Figure 7 the embodiment of Figure 6 in an assembled state;
    • Figure 8 a detailed view of the embodiment of Figure 6 in the assembled state of Figure 7;
    • Figure 9 yet another example of an embodiment of an intraocular lens system;
    • Figure 10 the embodiment of Figure 9 in an assembled state;
    • Figure 11 a detailed view of the embodiment of Figure 9 in the assembled state of Figure 10.
    DETAILED DESCRIPTION
  • For a better understanding of the invention like parts in the drawings are to be denoted with like reference numerals.
  • Figure 1 depicts a cross section of an eye, in particular a cross section of the eye 100 of a human being. The eye 100 is a sense organ capable of vision having an almost spherical configuration. Seen in the direction of light impinging on the eye, the anterior, frontal side of the eye 100 is formed by the cornea 107 having a stronger curvature comparted to the posterior side, being the sclera 101. The limbus connects the cornea 107 and the sclera 101. The cornea 107, the iris 110 and the lens capsule 106 form the anterior chamber 108 filled with aqueous humor liquid. Behind the lens 106 the vitreous body 105 is filled with vitreous gel.
  • The lens 106 is suspended in the eye by means of the ciliary body 111 composed of ciliary muscle and fibers. Reference numeral 109 denoted the posterior chamber present between the lens 106, the ciliary body 111 and the iris 110. The fundus or area opposite to the lens 106 at the posterior side of the eye 100 includes the macula 103, as well as the retina, being the innermost tissue layer containing the rod and cone cells. Also shown is the optic nerve 104 leaving the eye 100 at its posterior side towards the brains. Reference numeral 102 denotes the choroid.
  • The clear lens 106 is a transparent, biconvex structure in the eye that, along with the cornea 107 refract impinging light to be focused on the retina. The shape of the lens 106 can be changed resulting in a change of the focal distance of the eye 100 allowing the eye to focus (accommodation) on objects at various distances. Herewith the eye - under normal physical functionality - is able to form a sharp image of the object of interest on the retina.
  • The lens 106 is composed of three parts being the lens capsule, the lens epithelium, and the lens fibers. The lens capsule forms the outermost layer of the lens and the lens fibers form the bulk of the interior of the lens. The cells of the lens epithelium, located between the lens capsule and the outermost layer of lens fibers, are found predominantly on the anterior side of the lens but extend posteriorly just beyond the equator.
  • The lens capsule is a smooth, transparent basement membrane that completely surrounds the lens. The lens capsule is elastic and is composed of collagen and its shape can be changed for focusing purposes, also called accommodation of the lens 106.
  • Due to disease or disorder the eye 100 can undergo a surgical treatment in order to replace the affected lens 106 with a modular intraocular lens assembly (IOL) according to the invention. For example, a modular IOL according to one or more embodiments of the present invention can be implemented to treat cataracts, large optical errors in myopic (near-sighted), hyperopic (far-sighted), and astigmatic eyes, ectopia lentis, aphakia, pseudophakia, and nuclear sclerosis.
  • Figure 2 discloses a first embodiment of a modular intraocular lens system (IOL) according to an example of the invention. The IOL is indicated with reference numeral 1 and is composed of a primary component 10 which serves as a base component for implant in the capsular bag of an eye as described in combination with Figure 1 above. The intraocular primary, base component 10 interacts with an intraocular secondary, optical component indicated with reference numeral 20.
  • The intraocular primary, base component comprises a body 10 exhibiting a flat configuration and comprises a first primary component body part indicated with reference numeral 10a and a second primary component body part indicated with reference numeral 10b. The first primary component body part 10a of the intraocular primary component body 10 is configured to fit within the lens capsule or capsular bag 106 of the eye 100. Preferably, the first primary component body part 10a of the body 10 has an outer dimension or equatorial perimeter which is equal to the inner perimeter of the capsular bag or lens capsule 106.
  • The second primary component body part 10b of the intraocular primary component body 10 is configured to be positioned outside the lens capsule or capsular bag 106 and in the posterior chamber 109 of the eye. In a preferred, yet alternative embodiment the second primary component body part is configured to be positioned at the same level as the anterior surface line of the lens capsule and in the posterior chamber of the eye. The outer perimeter or outer circumference of the second primary component body part 10b of the intraocular primary, base component 10 is indicated with reference numeral 11a. In another example the first primary component body part 10a of the primary, base component 10 may have an equatorial perimeter greater than or equal or even smaller to the inner, capsulorhexis perimeter of the capsular bag 106.
  • The intraocular secondary, optical component 20 consists of an optical body 21 with an optical axis 23 which also is the cylindrical symmetric axis of the complete assembly of the intraocular lens system (primary and secondary components assembled together). In an example the outer dimensions of the intraocular secondary, optical component 20 are less than the outer dimensions of the second primary component body part 10b of the intraocular primary, base component 10. This allows for and guarantees a proper support and mounting of the secondary component 20 on (and/or in) the second primary component body part 10b.
  • In another example the secondary component may have an outer dimension , which is equal or smaller than than the capsulorhexis perimeter.
  • The primary, base component 10 and the secondary, optical component 20 of the modular IOL system 1 may be formed of the same, similar or different materials. Suitable materials may include, for example, acrylate, base materials, silicon materials, hydrophobic polymers or hydrophilic polymers. Such materials may have shape-memory characteristics. For example, materials comprising the optical parts of the IOL system can be silicon, PMMA, hydrogels, hydrophobic acrylic, hydrophilic acrylic and/or other transparent materials commonly used for intraocular lenses. The non-optical parts of the modular IOL assembly might include nitinol, polyethylene sulfone and/or polyimide.
  • In general it should be noted that the modular IOL system according to the invention is composed of two components, indicated already as the intraocular primary (base) component 10 (comprising the interconnected first and second primary body parts 10a and 10b) and intraocular secondary (optical) component 20. It is noted that the intraocular primary, base component functions as a support base for accommodating the intraocular secondary, optical component. As such, but not limited, the primary, base component 10 only performs a support function and does not provide any optical correction, the latter function is solely or predominantly performed by the intraocular secondary, optical component 20.
  • However, in yet another example it is also possible that the primary, base component 10 does provide some optical correction together with the secondary, optical component 20 and as such the modular IOL system is composed of a primary lens and a secondary lens part.
  • The positioning or implanting of the modular IOL system 1 in the capsular bag of the eye 100 is performed by a suitable, known ophthalmology surgical tools, in which the modular IOL is accommodated in a folded or rolled-up manner. Once inserted in the capsular bag, the rolled-up modular IOL system is to be ejected from or driven out the surgical tool into the capsular bag and during the ejection or insertion in the capsular bag the rolled-up modular IOL system automatically unrolls into its flat configuration as depicted in Figure 2. In the unrolled configuration the modular IOL system occupies the space in the capsular bag.
  • The second primary component body part 10b of the primary, base component 10 is provided with a center hole 11c defining an inner circumference 11b. Within said center hole 11c the secondary, optical component 20, and in particular the optical body 21 of the secondary, optical component 20, can be accommodated. As such, the outer circumference 21a of the optical body 21 of the secondary, optical component 20 is more or less conformal to the inner circumference 11b of the center hole 11c provided in the second primary component body part 10b of the primary, base component 10. In another embodiment, the outer circumference 21a of the optical body 21 of the secondary, optical component 20 is slightly smaller than the inner circumference 11b of the center hole 11c. This embodiment is depicted in Figure 4 and Figure 5.
  • The accommodation of the optical body 21 of the secondary, base component 20 in the center hole 11c of the second primary component body part 10b of the primary, base component 10 allows for an adjustment of the optical body 21 (hence the optical axis 23 thereof) relative to the primary, base component 10. As such, with the modular IOL according to the examples as shown in Figure 2 (and Figure 3) as well as in Figure 4 (and Figure 5) it is possible to correct the optical dioptric characteristic of the modular IOL. This is performed by replacement of the secondary, optical component 20 (the optical lens) with another example of a secondary, optical component without the removal of the complete IOL from the capsular bag. This is beneficial for the welfare of the patient during treatment, as the surgical treatment is less complex and burdensome, as the surgical removal and replacement of the secondary, optical component 20 takes place in the posterior chamber 109 of the eye. This, because the first primary component body part 10a of the primary, base component 10 remains inside the capsular bag or lens capsule 106, whereas the second primary component body part 10b of the primary, base component 10 containing the secondary, optical component 20 to be replaced is positioned in the posterior chamber 109 and thus easy access and manipulation by the surgeon is allowed whilst replacing the secondary, optical component 20. Herewith, the surgical procedure is less drastic compared to the implanting/replacement techniques associated with prior art modular IOLs.
  • In addition, the modular IOL according to the examples of the present invention also allows for an easy manipulation, displacement or even removal of the secondary, optical component accommodated in the second primary component body part 10b positioned in the posterior chamber 109 relative to the first primary component body part 10a the primary, base component 10 being deployed in the capsular bag 106. In particular, the optical body 21 can be displaced relative to the primary, base component 10 by rotating around the optical axis 23 or, as shown in the example of Figure 4 and Figure 5, by displacing the optical body 21 in a transverse direction over a certain distance relative to the optical axis 23 within the oversized center hole 11c provided in the second primary component body part 10b of the primary, base component 10.
  • In either embodiment as disclosed in Figure 2 and Figure 4, the secondary, optical component 20 is provided with several secondary flanges, two flanges in Figure 2 indicated with reference numeral 22a-22b (in Figure 2 and Figure 3) and four flanges indicated with reference numerals 22a-22d in Figures 4 and 5. The secondary flanges 22a-22d are accommodated in suitable flange openings 12a-12d provided in the second primary component body part 10b of the primary, base component 10.
  • Herewith, a proper confinement of the secondary, optical component 20 in the second primary component body part 10b of the primary, base component 10 is guaranteed, as the first primary component body part 10a of the primary, base component 10 is properly and securely placed inside the capsular bag 106 and thus forms a stable support face for the secondary component 20.
  • Proper confinement or retaining of the first primary component body part 10a of the primary, base component 10 within the capsular bag 106 is guaranteed as in a further example the first primary component body part 10b of the primary, base component 10 is provided with several support flanges 14a-14d. In one embodiment, the support flanges 14a-14d extend from the first primary component body part 10a of the primary, base component 10. In particular, as shown in the embodiment of Figure 2 and in particular Figure 3, the support flanges 14a-14d extend outside and away from the plane formed by the flat configuration of the first primary component body part 10a of the primary, base component 10.
  • As such, the second primary component body part 10b of the primary, base component 10 together with the secondary, optical component 20 contained therein are positioned further in the anterior direction which improves access and manipulation of the secondary, optical component 20 in order to adjust or improve its orientation relative to the optical axis 23 and/or the primary, base component 10.
  • In another example, the support flanges 14a-14d extend away from the outer circumference of the first primary component body part 10a of the primary, base component 10, whereas the support flanges 14a-14d are also positioned and extending within the plane formed by the first primary component body part 10a of the primary, base component 10. This latter configuration is shown in Figures 4 and 5 resulting in a modular IOL having a limited dimension seen in the direction of the optical axis of the eye (anterior-posterior direction).
  • In either embodiment the support flanges 14a-14d extending from the first primary component body part 10a of the primary, base component 10 abut against the inner circumference of the capsular bag 106 and as such provide a stability to the primary, base component and also allow a more efficient correction of the secondary, optical component 20 relative to the stabilized primary, base component 10.
  • Correcting the position of the secondary, optical component 20 relative to the second primary component body part 10b of the primary, base component 10 is further effectuated due to the presence of adjustment openings 24a-24d in every secondary flange 22a-22d. The adjustment openings 24a-24d serve as contact or gripping point for the tip of a surgical tool such as sinskey hooks for displacing the secondary, optical component 20 accommodated inside the center hole 11c of the second primary component body part 10b of the primary, base component 10 relative to the optical axis 23. As each secondary flange 22a-22d is accommodated in a flange opening 12a-12d of the second primary component body part 10b of the primary, base component 10, manipulation of the secondary, base component 20 using the tip of a surgical tool positioned in one of the adjustment or gripping openings 24a-24d may result in a limited rotation of the optical body 20 around the optical axis 23. Also a (slight) transverse displacement of the optical body 20 relative to the optical axis 23 can herewith be effected, for example in either X- or Y-direction wherein the X- and Y-directions denote orthogonal axes both intersecting the optical axis 23 and running across the opposite secondary flanges 22a-22b and 22c-22d respectively.
  • In particular, the adjustment or gripping openings 24a-24b are positioned exactly opposite to each other on an equatorial or diametrical line crossing the optical axis 23. The same applies to the adjustment or gripping openings 24c and 24d which are also located opposite to each other on an equatorial (diametrical) line crossing the optical axis 23 and located perpendicular to the equatorial (diametrical) line between the adjustment openings 24a-24b and the optical axis 23.
  • The adjustment of the optical body 20 relative to the second primary component body part 10b of the primary, base component 10 by means of rotation around the optical axis 23 or transverse displacement of the optical body 20 within the oversized center hole 11c as shown in the example of Figure 4, allows for a proper correction of the optical axis 23 relative to the macula and retina 103 of the eye.
  • The embodiments as shown in Figures 2 and 3 as well as in Figures 4 and 5 allow for a less drastic replacement of the secondary, optical component 20 contained in the second primary component body part 10b from the static first primary component body part 10a of the primary, base component 10 which first body part 10a remains in the capsular bag 106, as outlined before. The examples also allow for correction of the orientation of the secondary, optical component 20 relative to the macula and retina of the eye.
  • In Figure 6 yet another example of an embodiment of an intraocular lens system according to the invention is shown, combined with Figure 7 showing the embodiment of Figure 6 in an assembled state and Figure 8 showing a detailed view of the embodiment of Figure 6 in the assembled state of Figure 7. Also in the Figures 6-8 like parts are denoted with like reference numerals as used in the Figures 1-5.
  • Exhibiting a similar functionality as the embodiments discussed above, the modular IOL system as shown in Figures 6-8 is also composed of two components, reference numerals 10 and 20. The intraocular primary, base component comprises a body 10 exhibiting a flat configuration and comprises a first primary component body part indicated with reference numeral 10a and a second primary component body part indicated with reference numeral 10b. The first primary component body part 10a of the intraocular primary component body 10 is configured to fit within the lens capsule or capsular bag 106 of the eye 100. Preferably, the first primary component body part 10a of the body 10 has an outer dimension or equatorial perimeter which is equal to the inner perimeter of the capsular bag or lens capsule 106.
  • The second primary component body part 10b of the intraocular primary component body 10 is configured to be positioned outside the lens capsule or capsular bag 106 and in the posterior chamber 109 of the eye. The outer perimeter or outer circumference of the second primary component body part 10b of the intraocular primary, base component 10 is indicated with reference numeral 11a.
  • Similarly, the intraocular secondary, optical component 20 consists of an optical body 21 having an optical axis 23, which also is the cylindrical symmetric axis of the complete assembly of the intraocular lens system (primary and secondary components assembled together). In this embodiment the secondary, optical component 20 is provided with several secondary flanges at its the outer circumference 21a, in particular four flanges indicated with reference numerals 22a-22d (similar as in Figures 4 and 5). However also two flanges 22a-22b can be implemented similar as the embodiment in Figure 2 and 3, or even three flanges. In all flange configurations having 2, 3 or 4 flanges, it is preferred to have the flanges positioned equidistant at the outer circumference 21a of optical body of secondary, optical component 20.
  • This facilitates the placement of the secondary, optical component 20 on the second primary component body part 10b of the intraocular primary component body 10 and allows also for easy adjustment by rotating of the optical body 21 relative to the primary, base component 10 around the optical axis 23.
  • In this embodiment each flange 22a-22d is provided with a rounded edge 25, a detail of the rounded edge 25 being shown in Figure 8. Said rounded edge 25 is arranged for hooking around the outer circumference edge 11a of first primary component body part 10. The hooking functionality is effectuated by a slight deformation of each flange 22a-22d due to its flexible material by a bending force and hooking the rounded edge 25 around the outer circumference edge 11a as shown in Figure 8, allowing the rounded edge 25 to snap or click behind the edge 11a and creating an interlocking connection between the secondary, optical component 20 on the second primary component body part 10b of the intraocular primary component body 10.
  • This interlocking connection can easily be released or removed by applying a proper deformation force on each flange 22a-22d, thereby unhooking the rounded edge 25 from the circumference edge 11a for example for replacement of the secondary, optical component 20.
  • This interlocking connection also allows for an easy adjustment of the secondary, optical component 20 by rotating of the optical body 21 relative to the primary, base component 10 around the optical axis 23. The adjustment of the secondary, optical component 20 by rotating relative to the second primary component body part 10b of the primary, base component 10 can be facilitated as additionally the outer circumference edge 11a is provided with one or more support knobs 26. These knobs 26 support the secondary, optical component 20 on several distinct supporting points thereby reducing the overall contact surface between the secondary, optical component 20 and the second primary component body part 10b, thus reducing friction during adjustments.
  • Another embodiment as shown in the Figures 9-10-11 shows significant resemblance with the embodiment of Figure 4. Here the modular IOL system as shown is also composed of two components, reference numerals 10 and 20. The intraocular primary, base component comprises a body 10 exhibiting a flat configuration and comprises a first primary component body part indicated with reference numeral 10a and a second primary component body part indicated with reference numeral 10b. The first primary component body part 10a of the intraocular primary component body 10 is configured to fit within the lens capsule or capsular bag 106 of the eye 100. Preferably, the first primary component body part 10a of the body 10 has an outer dimension or equatorial perimeter which is equal to the inner perimeter of the capsular bag or lens capsule 106. The second primary component body part 10b of the intraocular primary component body 10 is configured to be positioned outside the lens capsule or capsular bag 106 and in the posterior chamber 109 of the eye.
  • The secondary, optical component 20 is provided with several (four) flanges indicated with reference numerals 22a-22d. The secondary flanges 22a-22d are accommodated in suitable flange openings 12a-12d provided in the second primary component body part 10b of the primary, base component 10. Herewith, a proper confinement of the secondary, optical component 20 in the second primary component body part 10b of the primary, base component 10 is guaranteed, as the first primary component body part 10a of the primary, base component 10 is properly and securely placed inside the capsular bag 106 and thus forms a stable support face for the secondary component 20.
  • Proper confinement or retaining of the first primary component body part 10a of the primary, base component 10 within the capsular bag 106 is guaranteed as in a further example the first primary component body part 10b of the primary, base component 10 is provided with several support flanges 14a-14b. In this embodiment, the support flanges 14a-14b extend from the first primary component body part 10a of the primary, base component 10. In particular, as shown in the embodiment of Figure 9 and in particular Figure 11, the support flanges 14a-14b extend outside and away from the plane formed by the flat configuration of the first primary component body part 10a of the primary, base component 10.
  • As such, the second primary component body part 10b of the primary, base component 10 together with the secondary, optical component 20 contained therein are positioned further in the anterior direction which improves access and manipulation of the secondary, optical component 20 in order to adjust or improve its orientation relative to the optical axis 23 and/or the primary, base component 10.
  • The support flanges 14a-14b extending from the first primary component body part 10a of the primary, base component 10 abut against the inner circumference of the capsular bag 106 and as such provide a stability to the primary, base component and also allow a more efficient correction of the secondary, optical component 20 relative to the stabilized primary, base component 10.
  • In all embodiments the first primary component body part of the primary component may provide additional support to the lens capsule, whereas alternatively the second primary component body part is configured to be positioned at the same level as the anterior surface line of the lens capsule and in the posterior chamber of the eye. Additionally the contact between the optic system and the posterior surface of the lenticular capsule is prevented and thus the formation of posterior capsular opacity is avoided.
  • The static primary, base component 10, which is to receive the secondary, optical component 20 in the second primary component body part 10b can be chosen to be manufactured from a material having contrast enhancing color. Such a color contrasts with the color of the material of the secondary, optical component 20. For example, the color of the material of the static primary, base component 10 can be darker that the color of the material of the secondary, optical component 20. The static primary, base component 10 can also be provided locally with a contrast enhancing color.
  • For example, certain parts of the static primary, base component 10 can have a color difference with respect to the color of the material of the secondary, optical component 20 as well as with respect to other parts of the static primary, base component 10 at locations on the static primary, base component 10 closely or near the secondary, optical component 20 being accommodated in the second primary component body part 10b of the primary, base component 10. In an example, said color difference can be applied to the circumference 11b of the center hole 13, thereby enhancing the contrast between the secondary, optical component 20 being accommodated in the center hole 13.
  • With the above contrast enhancements (color differences) it is possible to the optical system to enhance a better contrast resolution and a better visual acuity as well as reducing possible complains of disfothopsy due to restricting light dispersion through the periphery of the optic system. Moreover, as it can function as a partial closed esfincter, this also avoids the creation of glare at night.
  • LIST OF REFERENCE NUMERALS
  • 1
    first embodiment of modular intraocular lens system
    1'
    second embodiment of modular intraocular lens system
    10
    primary, base component
    10a
    first primary component body part
    10b
    second primary component body part
    11a
    outer circumference of second primary component body part
    11b
    inner circumference of center hole of second primary component body part
    11c
    center hole of primary, base component 10
    12a-12d
    flange opening of second primary component body part
    13
    center hole in first primary component body part
    14a-14d
    primary component support flanges
    20
    secondary, optical component
    21
    optical body of secondary, optical component
    21a
    outer circumference of optical body of secondary, optical component
    22a-22d
    secondary flanges of secondary, optical component
    23
    optical axis
    24a-24d
    adjustment opening of secondary flanges
    25
    rounded edge of secondary flange
    26
    support knob on second primary component body part
    100
    eye
    101
    sclera
    102
    choroid
    103
    macula and retina
    104
    optic nerve
    105
    vitrous body
    106
    lens capsule (capsular bag)
    107
    cornea
    108
    anterior chamber
    109
    posterior chamber
    110
    iris
    111
    ciliary body

Claims (14)

  1. An intraocular lens system (1, 1') for implantation into a lens capsule (106) of an eye (100) of human or animal body, said lens capsule (106) having a capsulorhexis perimeter, said intraocular lens system (1,1') comprising:
    i) an intraocular primary component (10) having a body exhibiting a flat configuration; and
    ii) an intraocular secondary component (20) having an optical body with an optical axis (23),
    wherein the primary component (10) includes a first primary component body part (10a) configured to fit within the lens capsule (106) and a second primary component body part (10b) configured to be positioned outside the lens capsule (106) and in the posterior chamber (109) of the eye (100) and wherein the second primary component body part (10b) is configured to releasably receive the secondary component (20) in the posterior chamber (109) of the eye (100) to provide optical correction, such that the secondary component (20) is movable relative to the primary component (10).
  2. A system (1) according claim 1, wherein the second primary component body part (10b) is configured to be positioned at the same level as the anterior surface line of the lens capsule (106) and in the posterior chamber (109) of the eye (100).
  3. A system (1) according to claim 1 or 2, wherein the primary component (10) includes a center hole extending in an anterior-posterior direction, wherein the hole is sized and configured to receive the secondary component (20) in the second primary component body part. (10)
  4. A system (1) according to any one or more of the claims 1-3, wherein the optical body of the secondary component (20) is accommodated within the plane formed by the flat configuration of the second body part (10b) of the primary component (10).
  5. A system (1) according to any one or more of the claims 1-3, wherein the optical body of the secondary component (20) is positioned outside the plane formed by the flat configuration of the second body part (10b) of the primary component (10).
  6. A system (1) according to any one or more of the preceding claims, wherein the primary component (10) is provided with two or more primary support flanges (14a-14d) extending from the first body part (10).
  7. A system (1) according to claim 6, wherein said primary support flanges (14a-14d) extend in the plane formed by the flat configuration of the first body part (10a) of the primary component (10b).
  8. A system (1) according to claim 6, wherein said primary support flanges (14a-14d) extend outside the plane formed by the flat configuration of the first body part (10a) of the primary component (10).
  9. A system (1) according to any one or more of the preceding claims, wherein the secondary component (20) comprises multiple secondary flanges (22a-22d) extending away from the optical axis (23) and in the plane formed by the optical body of the secondary component (20).
  10. A system (1) according to claim 9, wherein each secondary flange (22a-22d) is movable accommodated in an flange opening (12a-12d) provided in the circumference of the second body part (10b) of the primary component (10).
  11. A system (1) according to claim 9 or 10, wherein each secondary flange (22a-22d) is provided with an opening (24a-24d).
  12. A system (1) according to claim 9, wherein each secondary flange (22a-22d) is provided with a rounded edge (25), said rounded edge (25) arranged for hooking around the outer circumference of first primary component body part (10a).
  13. A system (1) according to any one or more of the preceding claims, wherein the primary component (10) constitutes a support and the secondary component (20) constitutes a lens.
  14. A system (1) according to any one or more of the preceding claims, wherein the primary component (10) is manufactured from a material having a contrast enhancing color relative to the secondary, optical component (20).
EP18182179.4A 2017-07-07 2018-07-06 Intraocular lens system for implantation into a lens capsule of an eye of human or animal being Active EP3424464B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NL2019196A NL2019196B1 (en) 2017-07-07 2017-07-07 Intraocular lens system for implantation into a lens capsule of an eye of human or animal being.
NL2019584 2017-09-20

Publications (2)

Publication Number Publication Date
EP3424464A1 EP3424464A1 (en) 2019-01-09
EP3424464B1 true EP3424464B1 (en) 2020-06-24

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EP18182179.4A Active EP3424464B1 (en) 2017-07-07 2018-07-06 Intraocular lens system for implantation into a lens capsule of an eye of human or animal being

Country Status (2)

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EP (1) EP3424464B1 (en)
ES (1) ES2808136T3 (en)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6991651B2 (en) * 2002-11-27 2006-01-31 Valdemar Portney Adjustable intraocular lens system and intraocular lenses therefor
US6960231B2 (en) * 2003-07-14 2005-11-01 Alcon, Inc. Intraocular lens system
CA3103252C (en) 2012-01-24 2023-06-13 The Regents Of The University Of Colorado, A Body Corporate Modular intraocular lens designs and methods
EP3250152A1 (en) * 2015-01-30 2017-12-06 Clarvista Medical, Inc. Modular intraocular lens designs

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None *

Also Published As

Publication number Publication date
EP3424464A1 (en) 2019-01-09
ES2808136T3 (en) 2021-02-25

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